Gelatinous body protection article having a therapeutic additive

ABSTRACT

The present invention is directed to a vitamin additive such as Vitamin A, B12, C, D, E, incorporated into the thermoplastic material of a sock, glove or like body protection article. The thermoplastic material is preferably a block copolymer such as SEBS, SEPS and SEEPS copolymer. Additionally, the thermoplastic material can include natural oils such as grape seed oil, avocado oil, jojoba oil, canola oil, ceramides and aloe.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention generally relates to a body protection article,and more particularly, to a body protection article comprising agelatinous composition having an additive formulation for treating theprotected skin. The body protection article can include a glove, socks,wrist band, brace for the knee, ankle, elbow and the like, or a shapedpad sized to cover any part of the body requiring delivery of atherapeutic active formulation to the skin. The gelatinous compositionhelps keep the skin moist while the therapeutically active formulationbeneficially affects the well-being of the skin, such as skin sensitiveto ultra violet light, burned skin, skin healing after a surgicalprocedure and the like.

2. Prior Art

It is known in the prior art to incorporate an additive into agelatinous material formed into an article for wearing on the body toaffect the well-being of the person. For example, U.S. Pat. Nos.5,098,421; 5,167,649; 5,181,914; and 5,330,452, all to Zook describevarious devices comprising a viscoelastic gel pad havingpharmacologically active agents incorporated into the gel. U.S. Pat. No.4,842,931 to Zook describes a pad made from a soft viscoelastic gelmaterial containing a high percentage of plasticizing oil for equalizingpressure directed to corns, calluses, bunions and the like. It is alsoknown to apply medication to the skin for the purpose of treating dermalafflictions and for delivering medicine to the body through the dermis.An example of such an externally applied medication is disclosed in U.S.Pat. No. 4,879,274 to Kamiya et al. which describes creams, ointmentsand the like comprising an α-monoglyceryl ether, a physiologicallyactive material and an oily material. The physiologically activematerial comprises compounds such as drugs, growth hormones and the likeincluding vitamins, for example, Vitamins A and B₁₂.

However, what is needed is a body protection article such as a glove,socks, shaped pad and the like that is comprised of a therapeuticallyactive formulation-containing gelatinous composition that impartsbeneficial properties to the skin protected by the article. Suchbenefits include, but are not limited to, reducing scar tissue fromburned skin and skin healing from a surgical procedure by maintainingthe skin in a moist and lubricated state, treatment of skin blemishesand providing gentle compression to cushion and help absorb shock forcesdirected to the body.

SUMMARY OF THE INVENTION

The body protection article according to the present invention comprisesa thermoplastic, gelatinous elastomeric composition containing atherapeutically active formulation as an additive incorporated therein.When the gelatinous composition is intimately combined with a substratesuch as a cloth material, paper or a polymeric film provided as a pieceof clothing or a shaped pad sized to cover a particular part of thebody, the therapeutically active formulation is released from the gel toaffect the well-being of the person wearing the article. The gelatinouscomposition is preferable a block copolymer of the general configurationpoly(styrene-ethylene-butylene-styrene),poly(styrene-ethylene-propylene-styrene) andpoly(styrene-ethylene-ethylene-propylene-styrene) combined within aplasticizing oil. Preferred therapeutically active formulation includesvitamin and/or natural oil additives.

These and other aspects of the present invention will become moreapparent to those skilled in the art by reference to the followingdescription and to the appended drawings.

BRIEF DESCRIPTION OF THE INVENTION

FIG. 1 is an elevational view of a glove according to the presentinvention.

FIG. 2 is a cross-sectional view along line 2--2 of FIG. 1.

FIG. 3 is an elevational view of a sock according to the presentinvention.

FIG. 4 is a cross-sectional view along line 4-4 of FIG. 3.

FIGS. 5 and 6 are photographs showing a surgically repaired hand beforeand after contact with a gelatinous composition having an additive fortreating the protected area.

DETAILED DESCRIPTION OF THE INVENTION

The file of this patent application contains two (2) color photographs.Copies of this application with the color photographs will be providedby the Patent and Trademark Office upon request and payment of thenecessary fee.

Turning now to the drawings, FIGS. 1 to 4 show various embodiments ofbody protection articles constructed according to the principles of thepresent invention. FIGS. 1 and 2 show a glove 10 and FIGS. 3 and 4illustrate a sock 12. However, those skilled in the art will readilyappreciate that the glove 10 and sock 12 shown are only exemplary, andmany different articles worn on the body are useful for imparting atherapeutically active formulation to the covered skin delivered from agelatinous elastomeric composition according to the present invention.In a broader sense, however, a body protective article is provided inany shape and size required to cover a particular body part includingshaped pads for use by women, men and children of all ages and sizes.

As shown in FIGS. 1 and 2, the glove 10 is comprised of a palm piece 14and a backhand piece 16, each a mirror image of the other. The palmpiece 14 includes a wrist portion 18 extending across a palm portion 20to four finger extensions 22 and a thumb extension 24. The back piece 16of the glove similarly has a wrist portion 26 extending across abackhand portion 28 to form finger extensions 30 and a thumb extension(not shown). The palm piece 14 and the backhand piece 16 are joinedtogether at their peripheral edges, such as by sewing, except at therespective wrist portions 18 and 26 providing an opening for putting ahand in the glove. A wrist piece 32 is folded over onto both sides ofthe palm piece 14 and the backhand piece 16 and sewn thereto surroundingthe glove opening to prevent fraying and to add integrity for pullingthe glove 10 onto a hand and for removing it therefrom.

The palm piece 14 and the backhand piece 16 are made from a clothmaterial having a gelatinous elastomeric composition 34 intimatelybonded thereto. The gelatinous composition 34 extends from a locationspaced from the wrist piece 32, as shown by the dashed line 36, to theends of the fingers 22, 30 and the thumb 24. Preferably the innersurface of the gelatinous composition closest to the human hand wearingthe glove 10 directly contacts the skin.

The cloth material can be a knitted fabric constructed of both syntheticand natural yarns. Suitable synthetic materials includes yarns such aspolyester, polyamide such as nylon, polyolefin, acrylic and like fiberswhile suitable natural fibers include cotton, cambric, wool, cashmere,rayon, jute and others.

FIGS. 3 and 4 show a sock 12 according to another embodiment of thepresent invention. The sock 12 is comprised of foot portion 50 leadingto an ankle portion 52 extending to a lower leg portion 54. The sock 12can be made having a generally tubular construction closed at one end bya toe portion 56 and seamed to provide a heel recess 58. In a similarmanner as the glove 10, the sock 12 is made from a knitted cloth havinga gelatinous elastomeric composition 60 intimately bonded thereto. Thecloth and gelatinous composition of the sock 14 are selected frommaterials similar to those used to construct the respective palm andbackhand pieces 14, 16 and the gelatinous composition 34 of the glove10.

The gelatinous material preferably directly contacts the skin in asimilar manner as shown and described with respect to the glove 10 tomedicate the protected skin by means of a therapeutically activeformulation as an additive incorporated therein. As shown in thecross-sectional view of FIG. 4, the gelatinous composition 60 extendsfrom the toe portion 56 to the heel 58 and has a width sufficient tocover the bottom of the foot.

Suitable gelatinous compositions are prepared by melt blending anadmixture comprising: about 1 part by weight of a high viscositytriblock copolymer of the general configurationspoly(styrene-ethylene-butylene-styrene) (SEBS),poly(styrene-ethylene-propylene-styrene) (SEPS) orpoly(styrene-ethylene-ethylene-propylene-styrene) (SEEPS), and fromabout 2 to about 15 parts by weight of a plasticizing oil. The blockcopolymer materials are commercially available from various sourcesincluding Shell under the Kraton designation, Kuraray Co, Ltd.

It will be understood that the block copolymer may comprise morecomplicated structures of either linear or branched configurations andmay contain any desired number of polymer blocks as long as each of themhas the identify and block molecular weights considered here. The blockmolecular weights employed for the present purpose are 5,000 to 75,000average molecular weight in the monoalkylarene polymer blocks(preferably 8,000 to 65,000) and 25,000 to 250,000 average molecularweight for the hydrogenated blocks of conjugated dienes (preferably35,000 to 110,000).

The block copolymers are characterized as having a Brookfield viscosityof a 20 weight percent solids solution of the block copolymer in tolueneat 25° C. of about 1,800 cps and higher. Less typically, the Brookfieldviscosity values of the block copolymer can range from about 1,800 cpsto about 30,000 cps or higher.

Particularly preferred moderate to high viscosity SEPS and SEEPS blockcopolymers include Kuraray's 2006 and 4055 designations, which exhibitsolution viscosities at 10weight %, 30° C. of about 7.1 and 59,respectively, and styrene contents, by weight, of about 35% and 30%,respectively. For a more detailed description of block polymers that areuseful with the present invention, reference is made to U.S. Pat. No.3,827,999 to Crossland, the disclosure of which is incorporated hereinby reference. Recent reviews of triblock copolymers are found in the"ENCYCLOPEDIA OF POLYMER SCIENCE AND ENGINEERING", Volumes 2 and 5,1987-1988; "Thermoplastic Elastomers", MODERN PLASTIC ENCYCLOPEDIA,1989; and Walker, B. M., Ed., et al., HANDBOOK OF THERMOPLASTICELASTOMERS, Van Nostrand Reinhold Co., 2nd Edition, 1988. Thesepublications are incorporated herein by reference.

The gelatinous block materials are mixed with a plasticizing oil toprovide compositions that can be softened or melted at elevatedtemperatures but which regain elastomeric properties at ambienttemperatures. Plasticizing oils particularly preferred for use inpracticing the present invention are well known in the art. They includerubber processing oils such as paraffinic and naphthionic petroleumoils, highly refined aromatic-free paraffinic and naphthionic food andtechnical grade white petroleum mineral oils, and synthetic liquidoligomers of polybutene, polypropene, polyterpene, etc. The syntheticseries process oils are high viscosity oligomers which are permanentlyfluid liquid nonolefins, isoparaffins or paraffins of moderate to highmolecular weight. Examples of representative commercially availableplasticizing oils include Amoco® polybutenes, hydrogenated polybutenesand polybutenes with epoxide functionality at one end of the polybutenepolymer and ARCO Prime, Duraprime and Tufflo oils. Other white mineraloils include: Bayol, Bernol, American, Blandol, Drakeol, Ervol, Gloria,Kaydol, Litetek, Lyondell's Duraprime series, Marcol, Parol, Peneteck,Primol, Protol, Sonrex, and the like. Generally, plasticizing oils withaverage molecular weights less than about 200 and greater than about 700may also be used.

According to the present invention, an effective amount of atherapeutically active formulation comprising a vitamin additive isincorporated into the gelatinous/plasticizing oil mixture. The vitaminadditive is selected from the group of Vitamin A, B₁₂, C, D, E, andmixtures thereof. Preferably, the vitamin additive is present in thetherapeutically active formulation at a concentration of, by weightpercent, about 1% to about 10%. The present invention furthercontemplates that any one of a number of medical grade natural oils canbe incorporated into the therapeutically active formulation which issubsequently added to the gelatinous/plasticizing oil mixture. Suitablemedical grade natural oils include grape seed oil, avocado oil, jojobaoil, canola oil, ceramides and aloe, and mixtures thereof. Preferably,the natural oil is present in the gelatinous elastomeric composition ata concentration of, by weight percent, about 5% to about 35%. After thetherapeutically active formulation has been provided, it is admixed withthe gelatinous material/plasticizing oil in a range of, by weight, about5% to about 50%. In some formulations, the natural oils can be used inlieu of the plasticizing oil to provide the resulting composition havingthe desired vicosity. In that case, the therapeutically activeformulation is added to the gelatinous material, by weight, up to about80%.

The gelatinous elastomeric composition can also contain useful amountsof conventionally employed additives such as stabilizers, antioxidants,antiblocking agents, colorants, fragrances, flame retardants, otherpolymers in minor amounts and the like to an extend not affecting orsubstantially decreasing the desired properties of the presentinvention.

The gelatinous elastomeric composition of the present invention may bemade non-adhering, non-sticking, non-tacky by incorporating therein asuitable amount of one or more of a metal stearate selected from calciumstearate, magnesium stearate, zinc stearate, aluminum stearate, and thelike, and a suitable amount of one or more of a fatty amide selectedfrom oleic acid, stearamide, behenamide, oleamide, erucamide,N,N"-ethylenebisstearamide, N,N"-ethylenebisoleamide, sterryl erucamide,erucyl erucamide, oleyl palmitamide, stearyl stearamide, erucylstearamide, and the like, or a suitable wax selected from polyethylene,polypropylene, microcrystalline, carnauba, paraffin, montan, candelilla,beeswax, ozokerite, ceresine, and the like.

The gelatinous elastomeric compositions of the present invention areprepared by blending together the block copolymer, plasticizing oil andthe therapeutically active formulation comprising the vitamin additiveand preferably the natural oil components as desired at about 23° C. toabout 100° C., forming a paste like mixture and further heating themixture to about 150° C. to about 250° C. until a homogeneous moltenblend is obtained. Lower and higher temperatures can also be utilizeddepending on the viscosity of the oils and amount of the block copolymerused. These components blend easily in the melt and a heated vesselequipped with a stirrer is all that is required.

An exemplary formulation for the therapeutically active component beforeincorporation into the gelatinous composition is as follows:

    ______________________________________                                        INGREDIENTS       WEIGHT %                                                    ______________________________________                                        Olive Oil         25.00                                                       Canola Oil        25.00                                                       Jojoba Oil Lite   25.00                                                       Grape Seed Oil    12.00                                                       N-stearyl phtosthingosine                                                                       10.00                                                       SoyBean Extract                                                               Vitamin E Acetate 2.00                                                        Fragrance         0.80                                                        Di-tert-butyl-t-cresol                                                                          0.20                                                        (Food Grade)                                                                  ______________________________________                                    

Thus, the present invention body protection articles are formed from amolten blend of the gelatinous elastomeric material, plasticizing oiland the therapeutically active formulation comprising the vitaminadditive, and optionally at least one of the enumerated natural oilsintimately bonded to a cloth, fabric, paper or a polymeric filmsubstrate by blending, melting, dipping, casting, injection molding,extruding and other conventional methods. For example, a preselectedrigidity of a molten gelatinous elastomer composition is cast directlyonto a cloth material to form the body protection article such as glove10 and sock 12. The gelatinous elastomer composition can also be diecast, cut to size and heat bonded to the substrate. Likewise, asubstrate such as of a cloth, paper, or a polymeric film material can bedipped into a preselected rigidity of a molten gelatinous elastomercomposition and re-dipped into the same or different composition of adifferent rigidity. The shaped composite article of the invention can beconventionally covered with protective skins of elastomeric film, paper,cloth, fabric or combinations thereof, as needed.

Such a gelatinous elastomeric composition contacted to a surgicalincision on a hand by means of a glove according to the presentinvention results in reduced scarring to the extent that aftertreatment, the area of an incision is nearly of the same texture andelasticity as that of undamaged skin. FIGS. 5 and 6 are respectivephotographs showing a hand before contact with a gelatinous compositionaccording to the present invention comprising a SEEPS block copolymer,plasticizing oil and the exemplary therapeutically active formulationset forth above, and about 42 days after contact with the composition ofthe present invention by means of glove 10. It is believed that thegelatinous elastomeric material serves as an occlusive blanket for"driving" the vitamin and natural oil additives into the skin. In thatmanner, the medical grade natural oil slowly dissipates from thegelatinous material onto the skin or scar to moisturize and lubricatethe affected area. This is particularly advantageous for reducing thediscoloration and thickness of both new and old keloid and hypertrophicscars in addition to improving the elasticity of the skin. The presentinvention can also be practiced in the form of shaped pads for treatingfacial conditions such as blemishes, liver spots, wrinkles and the like.

Many other therapeutic agents can be incorporated into the gelatinouselastomeric compositions of the present invention. For example,antifungal agents (fungal agents) such as ciclopirox, chloroxylenol,undecylenic acid, tolnaftate, miconizole, clotrizole, griseofulvin, andketoconozole may be incorporated therein. Antibiotic agents such asmupirocin, erythromycin, gentimycin, neomycin, polymyxin, bacitracin,tetracyclines, and the like may also be incorporated into the gelatinouscomposition. Antiseptic agents such as iodine, povidone-iodine,benzalkonium chloride, benzoic acid, chlorhexidine, nitrofurazone,benzoyl peroxide, hexachlorophene, phenol, resorcinol, andcetylpyridinium chloride likewise could be incorporated into the presentinvention. Furthermore, anti-inflammatories such as hydrocortisone,prednisone, triamcilolone, betamethasone and the like may beincorporated into the gelatinous composition. Still further, localanesthetics such as benzocaine, lidocaine, procaine, bupivicaine, aeutectic mixture of prilocaine and lignocaine, phenol, diphenhydramine,or the like may also be incorporated into the gelatinous composition.Additional agents that could be incorporated include penetrationenhancers such as dimethyl sulfoxide or octolyphenylpolyethelene glycol,keratolytic agents such as salicylic acid, enzymes such as proteases andnucleases, hormones such as insulin, vesicants such as cantharadin,caustics such as podophyllin, and a myriad of additionalpharmacologically active substances.

It is appreciated that various modifications to the inventive conceptsdescribed herein may be apparent to those of ordinary skill in the artwithout departing from the spirit and scope of the present invention asdefined by the appended claims.

What is claimed is:
 1. A method for reducing the discoloration andthickness of keloid and hypertrophic scars, comprising the steps of:a)providing a substrate; b) incorporating a first therapeutically activeagent into a gelatinous material comprising a block polymer, wherein thefirst therapeutically active agent is selected from the group consistingof Vitamins A, B₁₂, C, D, E, and mixtures thereof; c) incorporating asecond therapeutically active agent into the gelatinous material,wherein the second therapeutically active agent is a natural oilselected from the group consisting of grape seed oil, avocado oil,jojoba oil, canola oil, ceramides, aloe, and mixtures thereof; d)bonding the gelatinous material to the substrate; e) forming thesubstrate having the gelatinous material bonded thereto into a bodyprotection article; and f) wearing the body protection article on thekeloid or hypertrophic scar for an extended period of time.
 2. Themethod of claim 1 including selecting the gelatinous material from thegroup consisting of SEBS, SEPS and SEEPS, and mixtures thereof.
 3. Themethod of claim 1 including providing the body protection device as oneselected from the group consisting of a glove, sock, brace for a knee,ankle and elbow, and a shaped pad.
 4. The method of claim 1 includingwearing the body protection article for about 42 days.
 5. The method ofclaim 1 including selecting the substrate from the group consisting ofcloth, paper and a polymeric film, and mixtures thereof.
 6. The methodof claim 5 wherein the cloth is a synthetic material selected from thegroup consisting of polyester, polyamide, polyolefin and acrylic, andmixtures thereof.
 7. The method of claim 5 wherein the cloth is anatural material selected from the group consisting of cotton, cambric,wool, cashmere, rayon and jute, and mixtures thereof.
 8. The method ofclaim 1 wherein the gelatinous material further includes a third agentselected from the group consisting of an antifungal agent, an antibioticagent, an antiseptic agent, an anti-inflammatory agent, an anesthetic, apenetration enhancer, a keratotytic agent, an enzyme, a hormone and acaustic agent, and mixtures thereof.
 9. The method of claim 1 whereinthe gelatinous material is mixed with a plasticizing oil in a ratio ofabout 1:2 to 1:15.
 10. The method of claim 1 wherein the gelatinousmaterial is mixed with a plasticizing oil, the first therapeuticallyactive agent and the second therapeutically active agent at atemperature of about 23° C. to about 250° C.
 11. The method of claim 1wherein the gelatinous material is mixed with a plasticizing oil, thefirst therapeutically active agent, and the second therapeuticallyactive agent at a first temperature range of about 23° C. to about 100°C. to form a paste like mixture, followed by a further heating at asecond temperature range of about 150° C. to about 250° C.
 12. Themethod of claim 1 including rendering the gelatinous materialnon-adhering, non-sticking and non-tacky by incorporating therein ametal stearate, and at least one of a fatty amide and a wax.
 13. Amethod for reducing the discoloration and thickness of keloid andhypertrophic scars, comprising the steps of:a) providing a substrate; b)incorporating a natural oil selected from the group consisting of grapeseed oil, avocado oil, jojoba oil, canola oil, ceramides and aloe, andmixtures thereof, into a gelatinous material comprising a block polymer,wherein the gelatinous material is selected from the group consisting ofSEPS, SEEPS, and mixtures thereof; c) bonding the gelatinous material tothe substrate; d) forming the substrate having the gelatinous materialbonded thereto into a body protection article; and e) wearing the bodyprotection article on the keloid or hypertrophic scar for an extendedperiod of time.
 14. A method for reducing the discoloration andthickness of keloid and hypertrophic scars, comprising the steps of:a)providing a substrate; b) incorporating, by weight, about 25% olive oil,about 25% canola oil, about 25% jojoba oil, about 12% grape seed oil,about 10% N-stearyl phylosthingosine soybean extract, about 2% vitaminE, remainder inert ingredients into a gelatinous material comprising ablock polymer; c) bonding the gelatinous material to the substrate; d)forming the substrate having the gelatinous material bonded thereto intoa body protection article; and e) wearing the body protection article onthe keloid or hypertrophic scar for an extended period of time.